Sirtex gains European approval

Anti-cancer company Sirtex Medical (ASX:SRX) has been given the green light to begin marketing and sales of its lead product SIR-Spheres in the European Community.

The way has been cleared by the granting of an Annex 11 quality assurance and design examination certificate for SIR-Spheres by the British Standards Institute.

The approval covers the use of SIR-Spheres in the treatment of all forms of liver cancer including both primary and secondary liver cancer. The company said it has undertaken extensive market preparation in the UK, France, Germany and Benelux where it will begin sales activities directly. Sirtex estimates the potential market for Selective Internal Radiation Therapy (SIRT) in Europe will be worth more than $850 million annually.

But it expects Europes adoption of the technology to be slower than in the US where SIR-Spheres were approved by the FDA last March and are now being used in at least four high-profile US teaching and research centres.

The slower European take-up is due to different market drivers, fragmented re-imbursement systems and funding constraints, according to Sirtex.

To counter those pressures, Sirtex has appointed the EC reimbursement specialists Wyfold Consultancy.

Shares in Sirtex jumped 11 per cent on Wednesday after it made the announcement.

The shares hit a two-year high of $3.90 on the news before easing back to trade up eight percent at $3.78 in a higher overall market.

Additional reporting by Reuters